BMC Connector Cable Instructions for Use

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Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions noted in these instructions. Failure to do so may result in patient complications. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. I. DEVICE DESCRIPTION The Baylis Medical Connector Cable connects the BMC Radiofrequency Puncture Generator to Baylis Medical Radiofrequency Puncture Catheters and Wires. This Cable enables radiofrequency (RF) power to be delivered from the Generator to the puncture device. Detailed information concerning the Baylis Medical Radiofrequency Puncture Generator is contained in a separate manual that accompanies the Generator (entitled “BMC Radiofrequency Puncture Generator Instructions for Use”). In addition, detailed information concerning the radiofrequency puncture catheters and wires is contained in separate manuals that accompany these devices. The dimensions for the Connector Cable can be found on the device label and in section VII “Product Specifications.” The Connector Cable has a four-pin connector on one end that mates with the Generator and a connector at the other end, which mates with the puncture device. II. INDICATIONS FOR USE The intended use of the BMC Connector Cable is to connect the BMC RF Puncture Generator to Baylis Medical puncture catheters. III. CONTRAINDICATIONS The BMC Connector Cable is not recommended for use with any other RF generator or any other catheter/wire. IV. WARNINGS • The Connector Cable is a reusable device. Only use the validated cleaning and sterilization methods as described in section XI “Cleaning and Sterilization Instructions” to clean and sterilize the Connector Cable. No other cleaning and sterilization methods have been tested. Failure to properly clean and sterilize the device can cause patient injury and/or the communication of infectious disease(s) from one patient to another. • The Connector Cable must only be used with the BMC RF Puncture Generator and Baylis Medical RF puncture devices. Attempts to use it with other RF Generators and catheters or wires can result in electrocution of the patient and/or operator. • Laboratory staff and patients can undergo significant x-ray exposure during radiofrequency puncture procedures due to the continuous usage of fluoroscopic imaging. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure. V. PRECAUTIONS • Do not attempt to use the BMC Connector Cable or ancillary equipment before thoroughly reading the accompanying Instructions for Use. • Puncture procedures should be performed only by physicians thoroughly trained in the techniques of radiofrequency powered puncture in a fully equipped catheterization laboratory. • The sterile packaging should be visually inspected prior to use to detect any compromise. Ensure that the packaging has not been damaged. Do not use the equipment if the packaging has been compromised. • Visually inspect the cable to ensure there is no cracking or damage to the insulating material. Do not use the cable if there is any damage. • The BMC Connector Cable is intended for use with BMC RF Puncture devices only. • Never disconnect the BMC Connector Cable from the BMC RF Puncture Generator while the Generator is delivering RF power. • Never disconnect the BMC Connector Cable from the BMC RF Puncture Generator by pulling on the cable. Failure to disconnect the cable properly may result in damage to the cable. • Do not twist the Connector Cable while inserting or removing it from the Catheter Isolated Patient Connector on the Generator. Twisting the cable may result in damage to the pin connectors. • Do not bend the cable. Excessive bending or kinking of the cable may damage the integrity of the cable and may cause patient injury. Care must be taken when handling the cable. • Take precautions to limit the effects that the electromagnetic interference (EMI) produced by the Generator may have on the performance of other equipment. Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the Generator. • Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during radiofrequency power applications. • During power delivery, the patient should not be allowed to come in contact with ground metal surfaces. • In order to prevent the risk of ignition make sure that flammable material is not present in the room during RF power application. Baylis Medical Company relies on the physician to determine, assess and communicate to each individual patient all foreseeable risks of the Baylis Medical Radiofrequency Puncture System. VI. ADVERSE EVENTS Adverse events associated with the use of this device are similar to those indicated for the Baylis Medical Radiofrequency Puncture System. VII. PRODUCT SPECIFICATIONS Model Number RFP-102 Overall Useable Length 10 feet Generator Connector 4-pin Wire/Catheter Connector Single Socket VIII. INSPECTION PRIOR TO USE Perform the following checks before the patient is presented for the procedure. These tests will allow you to verify that the equipment you will use is in proper working order. Do these tests in a sterile environment. Do not use defective equipment. KEY ITEMS QUESTION? WARNINGS AND EXPLANATIONS The BMC Connector Cable is supplied Is the connector cable sterile for its initial use. Prior to each Sterility sterile? subsequent use it must be cleaned and sterilized. Ensure connectors and the cable have Have you done a no visible damage, such as discoloration, Visual Check visual check on the cracks, label fading, cable splice, or entire system? kinks. Do not use damaged equipment. IX. EQUIPMENT REQUIRED Puncture procedures should be performed in a specialized clinical setting which may be equipped with a fluoroscopy unit, radiographic table, physiologic recorder, emergency equipment and instrumentation for gaining vascular access. X. DIRECTIONS FOR USE Once the Baylis Medical RF puncture device is properly positioned at the puncture site, and the Generator is properly set up (following the instructions in the BMC Radiofrequency Puncture Generator Instructions for Use), the BMC Connector Cable can be used to connect the catheter or wire to the Generator. 1. Connect the generator connector end of the cable to the appropriate port on the BMC RF Puncture Generator as per the Generator Instructions for Use. The Connector Cable uses a circular connector, keyed for proper alignment. Gently line up the connector pins with the socket and push in until the connector fits firmly into the socket. Any attempt to connect the cable otherwise will damage the pins on the connector.

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Do not use excessive force in connecting the cable to the generator. Use of excessive force may result in damage to the connector pins. Secure the screw-on locking ring mechanism of the generator connector to the appropriate port on the BMC RF Puncture Generator as per the Generator Instructions for Use to complete the connection. 4. Firmly grasp the catheter connector end of the cable in one hand: a) For model RFP-102: Slowly insert the proximal end connector of the Baylis Medical RF puncture device into the opening of the catheter connector until the two connectors are fully mated. 5. The Puncture System is now ready to deliver RF power to the puncture site. 6. To disconnect the puncture device from the Connector Cable: a) For model RFP-102: Firmly grasp the plug of the catheter connector end of the cable in one hand and gently pull on the puncture device. 7. To disconnect the cable from the generator, rotate the locking ring of the generator connector counter clockwise to unlock, then grasp the connector firmly and gently pull it straight out of the socket. XI. CLEANING AND STERILIZATION INSTRUCTIONS DANGER The BMC Connector Cable is supplied sterile, however it must be cleaned and sterilized before each subsequent use as described in this Instructions for Use document. Failure to properly clean and sterilize the device can cause patient injury and/or the communication of infectious diseases from one patient to another. IMPORTANT The manufacturer recommends the user follow a quality control program for each sterilization cycle that meets or exceeds American Operating Room Nurses (AORN) Standards, Recommended Practices & Guidelines - 2000. This program includes, but is not limited to recording: • Type of sterilizer and cycle used • Lot control number • Load contents • Exposure time and temperature, if not provided by a recording chart • Operator’s name • Results of sterilization process monitoring (i.e. chemical, mechanical, biological) Cleaning and Decontamination 1. Ensure that blood and other contaminates do not dry on the BMC Connector Cable. 2. Visually inspect the cable for defect. 3. Rinse the cable with de-ionized water until colourless run-off water occurs. Once the water runs clear, soak the cable (except for the connectors at the ends of the cable) in de-ionized water at 22°C-48°C for 1 minute. Remove the cable from the water and scrub it with a soft bristle brush until it is visually clean. Note: Do not let the connectors soak. Wipe them as necessary until they are visually clean. 4. Soak the cable (except for the connectors) in an enzymatic cleaning solution (such as Terg-AZyme) for 20 minutes. Ensure that the temperature of the solution is below 55°C. Scrub again with a soft bristle brush, and rinse thoroughly using de-ionized water until all traces of detergent residue are removed. 5. Visually inspect the parts for debris. If any is present repeat steps 2 and 3. 6. Dry the cable with a clean, dry, lint free towel. 7. Place the cable on a sterilization tray. Sterilization For a prevacuum sterilizer: WRAPPED: 132°C-135°C (270°F-275°F) FOR 3-4 MIN. UNWRAPPED: “FLASH’ STERILIZATION 132°C FOR 4 MIN. NOTE: Only the above cleaning and sterilization methods have been validated for the BMC Connector Cable. No other cleaning and sterilization methods have been tested. Failure to follow these instructions can cause patient injury and/or the communication of infectious disease(s) from one patient to another. XII. CUSTOMER SERVICE AND PRODUCT RETURN INFORMATION If you have any problems with or questions about Baylis Medical Equipment contact our technical support personnel. NOTES: 1. In order to return products you must have a return authorization number before shipping the products back to Baylis Medical Company. 2. Baylis Medical will not accept any piece of used equipment without a sterilization certificate. Ensure that any product being returned to Baylis Medical has been cleaned, decontaminated and sterilized as per user instructions before returning it for warrantied service XIII. TROUBLESHOOTING The following table is provided to assist the user in diagnosing potential problems. PROBLEM COMMENTS TROUBLESHOOTING Generator Error In order to successfully Ensure that all connections Messages puncture tissue using are made: - puncture device to connector radiofrequency energy, the cable entire system must be - connector cable to generator connected and all devices - generator to power outlet must be in good working - generator to grounding pad order. 3.

Visually inspect the catheter/wire or cable for damage. Immediately discard any damaged equipment. If the problem persists discontinue use.

Connector Cable does not fit into the Isolated Patient Connector on the front panel of the generator XIV.

The connectors are designed to connect in a specific way for safety reasons. If the connector “keys” are out of line, the connectors won’t fit together LABELING AND SYMBOLS

For error messages encountered while attempting puncture, refer to the operator’s manual that accompanies the Generator. If errors persist, attach a new connector cable. If this solves the problem, discard the damaged connector cable. Check that the connector keys are lined up in the proper orientation. Ensure that the connectors are clean and unobstructed.

Manufacturer

DMR RFP Cables 3.3 V-17 22-Sep-2022